AbbVie Announces New Data from its Dermatology Portfolio and Pipeline at the 28th European Academy of Dermatology and Venereology (EADV) Congress -…

NORTH CHICAGO, Ill., Oct. 9, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that it will present new results evaluating the safety and efficacy of SKYRIZI (risankizumab) at 2.5 years in adult patients with moderate to severe plaque psoriasis, as well as additional data on HUMIRA (adalimumab) and the investigational JAK inhibitor upadacitinib, at the 28th European Academy of Dermatology and Venereology (EADV) Congress, October 9-13, in Madrid.

"Leveraging more than two decades of clinical experience with HUMIRA, AbbVie recently expanded its dermatology portfolio with the approval of SKYRIZI for patients living with moderate to severe plaque psoriasis," said Marek Honczarenko, MD, PhD, vice president, global immunology development, AbbVie. "The new data presented at EADV will advance the knowledge around new and existing treatments for serious skin diseases, like psoriasis, as well as diseases with high levels of unmet need, such as atopic dermatitis and hidradenitis suppurativa."

In addition to sharing new long-term data from the LIMMitless open-label extension study in moderate to severe plaque psoriasis, AbbVie will share results from its ongoing investigational Phase 2 program evaluating risankizumab for the treatment of psoriatic arthritis. Risankizumab is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.

In addition, Phase 2b results evaluating time to treatment response with upadacitinib, an oral JAK inhibitor, under investigation for patients with moderate to severe atopic dermatitis will be shared as an oral presentation. Upadacitinib is not approved for atopic dermatitis by any regulatory authority, and its safety and efficacy have not been established in this indication.

Additional presentations include efficacy and safety results further evaluating HUMIRA in hidradenitis suppurativa.

"Chronic skin diseases can have a significant physical and psychosocial impact on patients," said Jean-Marie Meurant, board president of the International Alliance of Dermatology Patient Organizations. "While progress has been made to improve the lives of patients, many still do not have access to the treatment and care they need and deserve. It's critical that the scientific community build upon current research to better understand these diseases and continue to keep the patient experience at the forefront of their efforts."

AbbVie Data at EADV

Risankizumab Abstracts Psoriasis

Psoriatic arthritis

Upadacitinib AbstractsAtopic dermatitis

HUMIRA AbstractsPsoriasis

Hidradenitis suppurativa

Disease State AbstractsHidradenitis suppurativa

About SKYRIZI (risankizumab) in the EU1

SKYRIZI (risankizumab) is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

Important EU Safety Information1

SKYRIZI is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients and in clinically important active infections. SKYRIZI may increase the risk of infection. In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, SKYRIZI should be used with caution. Treatment with SKYRIZI should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.

Prior to initiating treatment with SKYRIZI, patients should be evaluated for tuberculosis (TB) infection. Patients receiving SKYRIZI should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating SKYRIZI in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.

The most frequently reported adverse reactions were upper respiratory infections, which occurred in 13 percent of patients. Commonly (greater than or equal to 1/100 to less than 1/10) reported adverse reactions included tinea infections, headache, pruritus, fatigue and injection site reactions.

This is not a complete summary of all safety information. See the full summary of product characteristics (SmPC) at http://www.ema.europa.eu. Globally, prescribing information varies; refer to the individual country product label for complete information.

About Upadacitinib

Discovered and developed by AbbVie, upadacitinib is an investigational, oral, small molecule JAK inhibitor being studied for moderately to severely active rheumatoid arthritis and other immune-mediated inflammatory diseases.2-15 Phase 3 trials of upadacitinib in psoriatic arthritis, Crohn's disease, atopic dermatitis and ulcerative colitis are ongoing and it is also being investigated to treat ankylosing spondylitis and giant cell arteritis.10-15

About HUMIRA in the EU16

HUMIRA is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.

HUMIRA is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy.

Important EU Safety Information16

HUMIRA is contraindicated in patients with active tuberculosis or other severe infections such as sepsis, and opportunistic infections and in patients with moderate to severe heart failure (NYHA class III/IV). It is also contraindicated in patients hypersensitive to the active substance or to any of the excipients; serious allergic reactions including anaphylaxis have been reported. The use of HUMIRA increases the risk of developing serious infections, including hepatitis B reactivation, which may, in rare cases, be life-threatening. Rare cases of lymphoma and leukemia have been reported in patients treated with HUMIRA. On rare occasions, a severe type of cancer called hepatosplenic T-cell lymphoma has been observed and often results in death. A risk for the development of malignancies in patients treated with TNF-antagonists cannot be excluded. Rare cases of pancytopenia, aplastic anaemia, demyelinating disease, lupus, lupus-related conditions and Stevens-Johnson syndrome have been reported in patients treated with HUMIRA. The most frequently reported adverse events across all indications included respiratory infections, injection site reactions, headache and musculoskeletal pain.

This is not a complete summary of all safety information. Globally, prescribing information varies; refer to the individual country product label for complete information.

Full summary of product characteristics is available at: http://www.ema.europa.eu

About AbbVie

AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at http://www.abbvie.com. Follow @abbvie on Twitter, Facebook, LinkedIn or Instagram.

Forward-Looking Statements

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2018 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

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SOURCE AbbVie

Company Codes: NYSE:ABBV

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AbbVie Announces New Data from its Dermatology Portfolio and Pipeline at the 28th European Academy of Dermatology and Venereology (EADV) Congress -...